1. India rejects J&J’s attempt to extend patent on TB drug
In a victory for patients fighting for wider access to the crucial anti-tuberculosis drug Bedaquiline, the Indian Patent Office on Thursday rejected U.S. pharmaceutical giant Johnson & Johnson’s attempt to extend its monopoly on manufacturing the drug in India beyond July 2023.
J&J’s primary patents on Bedaquiline expire in July, paving the way for generic drug manufacturers such as Lupin and Macleods, among others, to produce Bedaquiline, thus ensuring cheaper and wider access to the drug. Currently, Bedaquiline tablets are priced at $400 per six-month treatment course.
Bedaquiline is a crucial drug in the treatment of multi-drug resistant TB patients for whom the first-line drug treatment has stopped working.
Since 2007, J&J had indulged in ‘evergreening’ — a strategy to extend the life of patents about to expire in order to retain revenues from them — by making multiple claims in its applications for patent extensions.
When the firm filed for evergreening of its patent on fumarate salt (a formulation salt of Bedaquiline), the practice was challenged by TB survivors Nandita Venkatesan and Phumeza Tisile.
“We filed a patent challenge in 2019, because we wanted to ensure that safer, oral and efficacious drug Bedaquiline was available to all people who need it,” Ms. Venkatesan told The Hindu.
Our attempt to break the monopoly of a pharma company over this life saving drug has been successful,” Ms. Venkatesan said.
‘No inventive step’
J&J had sought a patent extension on the basis of its claim that it had invented the method for making a derivative of quinoline in its salt form. However, in her order passed on Thursday, Latika Dawara, Assistant Controller of Patents and Designs, stated that the invention claimed was obvious and does not involve any inventive step, and is therefore non-patentable.
Section 3(d) of the Patents Act states that salt forms and derivatives of known substances are not patentable.
According to the latest available estimates, in 2019, over 55,000 patients who had developed multi-drug resistant TB could have benefited from access to Bedaquiline. As of March 2020, only a little over 10,000 of these patients had accessed the drug.
2. Govt. tapping technology to secure ancient scriptures for future: Shah
Union Home Minister Amit Shah on Thursday said the government was securing the knowledge in India’s ancient scriptures and manuscripts for the future through technology.
Inaugurating the ‘Vedic Heritage Portal’ created by the Indira Gandhi National Centre for the Arts (IGNCA) here, Mr. Shah said that with the help of this, the younger generation would be able to carry forward the knowledge and tradition of the Vedas and the Upanishads.
The IGNCA comes under of Ministry of Culture.
Mr. Shah also inaugurated a virtual museum ‘Kala Vaibhav’ based on 64 arts, through which, he said, the world would be more familiar with India’s architecture, painting, drama, music, and thereby the rich history of the country’s glorious culture.
The portal is a one-stop solution for common users and researchers seeking any information regarding Vedic heritage. It gives detailed information about oral traditions, textual tradition in form of published books/manuscripts, or implements, the IGNCA said.
3. U.P.’s ‘missing’ sarus crane that’s stirred up a hornet’s nest in the State’s politics
On March 21, the Uttar Pradesh Forest Department visited Mohammed Arif Khan to relocate a sarus crane, the State bird, from his home at Mandka village in Amethi to Raebareli’s Samaspur Bird Sanctuary. The bird, which Mr. Khan claims he found injured and lying unconscious in his fields last year, had taken a shine to the family after they took care of it for over two months.
“After treatment I thought it would fly away. We took it to the fields, but the bird refused to leave us. He was like family to me, and we ate and lived together,” said Mr. Khan.
Samajwadi Party (SP) president Akhilesh Yadav had visited Mr. Khan to witness the bonding. A day after the bird was taken to the sanctuary, Mr. Yadav, in a tweet, claimed that the bird was missing. He tagged a media report which quoted the Divisional Forest Officer (DFO) Rupesh Srivastava as saying this. “Such government negligence towards the State bird of U.P. is a serious matter. The BJP government should immediately find the sarus,” Mr. Yadav wrote in Hindi.
Mr. Khan, on March 22, sat with the SP president in a press conference in Lucknow where Mr. Yadav alleged that in the name of freeing the State bird, the administration took away the sarus crane from the person who was his family. “It remains to be seen what action is taken to free the bird from the one who feeds it,” said the SP chief at the press meet targeting Prime Minister Narendra Modi who had posted pictures feeding a peacock.
However, the administration said this was untrue and the whereabouts of the bird were clear. Mr. Srivastava told the media that the bird was seen in the sanctuary on Thursday and is not missing.
4. GST appellate tribunal may be headed by a former SC judge
New tax tribunal expected to address pile-up of unresolved legal cases, thus lowering the burden on courts and taxpayers; single-member bench will hear disputes involving less than ₹50 lakh
The Goods and Services Tax (GST) Appellate Tribunal is likely to be headed by a former Supreme Court judge or a former Chief Justice of a High Court and its framework may permit the resolution of disputes involving dues or fines of less than ₹50 lakh by a single-member bench.
Amendments to the GST laws to enable the tribunal’s constitution, are expected to be introduced in the Lok Sabha.
While there will be one principal bench of the Appellate Tribunal in New Delhi and several State benches, appeals pertaining to disputes of less than ₹50 lakh that don’t deal with a question of law could be decided by a single-member bench, as per the norms approved by the GST Council.
In February, the Council had reached a broad consensus on the long-awaited appellate body’s functioning. Tax experts said the delay in setting up the Appellate Tribunal has led to a pile-up of unresolved legal matters over the tax.
“Currently, taxpayers are filing writ petitions to directly move the High Court,” said Tanushree Roy, director at Nangia Andersen. “Establishment of Appellate tribunal would result in lower burden on the courts and taxpayers.”
5. EDITORIAL-01: A climate change survival guide to act on
The Intergovernmental Panel on Climate Change AR6 synthesis report is a sobering account of present and future damages to ecosystems
This week, the Intergovernmental Panel on Climate Change (IPCC) released the synthesis report of its Sixth Assessment Report (AR6) cycle, drawing together key findings from its six most recent reports. The report gains added legitimacy as its summary for policymakers is approved line-by-line by governments of the world. The United Nations Secretary General has called it a ‘survival guide for humanity’. The report can shape our collective response in this critical decade, which may be make-or-break for humanity, and is likely to be the last IPCC report for a few years.
The report confirms that human activity is ‘unequivocally’ driving global temperature rise, which has reached approximately 1.1° C above pre-industrial levels. While the rate of emissions growth has slowed in the past decade, humanity is estimated to be on a 2.8° C(2.1°-3.4° C range) trajectory by 2100. This temperature rise has already led to rapid and widespread impacts on climatic systems. It flags that “For any given future warming level, many climate-related risks are higher than assessed in AR5”. This new realisation underpins the considerable attention in the IPCC report to trajectories that constrain global warming to 1.5° C rather than 2° C. This relative focus on 1.5° C has two implications.
First, the amount of carbon that the world can cumulatively emit before reaching key temperature limits, i.e., the world’s ‘carbon budget’, is far lower for the 1.5° C than the 2° C target. Modelled global pathways suggest that limiting warming to 1.5° C (with a probability of >50% requires greenhouse gas (GHG) emissions to be reduced by 43% by 2030 (median estimate), while the same number for limiting warming to 2° C (probability of >67%) is 21%. Strikingly, it notes that the projected CO2 emissions over the lifetime of existing fossil fuel infrastructure without additional abatement already exceed the remaining carbon budget for 1.5° C.
Striving for a 1.5° C target implies deep and immediate reductions in emissions in all sectors and regions, which makes more salient different national circumstances and questions of climate equity and operationalisation of the United Nations Framework Convention on Climate Change’s core principle of Common but Differentiated Responsibility and Respective Capabilities. The IPCC report points out that humanity had already consumed 4/5ths of its total carbon budget for 1.5° C by 2019, with developed economies consuming the lion’s share. The report also notes that existing modelling studies, which are often used to assess emission trajectories, do not explicitly account for questions of equity. While from an impacts point of view, it is important to aspire to a 1.5°C target, the correspondingly lower carbon budget heightens questions of equity and who bears the responsibility for achieving these ambitious targets.
Second, the recognition of greater risks at lower temperatures points to the necessity of early climate adaptation. The report highlights that adaptation itself has limits, which implies that some losses and damages of climate change are inevitable. For example, the report finds that some coastal and polar ecosystems have already reached hard limits in their ability to adapt to a changing climate. The effectiveness of some of the adaptation options that are feasible and effective today (such as urban greening and restoration of wetlands) decreases with increasing warming. Importantly, the report cautions against certain forms of adaptation such as poorly planned seawalls — dubbed maladaptation — which can defer and intensify the impacts of climate for short term and often iniquitous adaptation gains. It also argues that at higher levels of warming, climate change could lead to cascading risks such as food insecurity, leading to migration, which are intensely challenging to manage. A logical corollary of these findings would be that because countries cannot entirely develop their way out of climate risk and vulnerability, mitigation remains essential.
The key message
So while the diagnosis is dire, what of the prognosis?
The leading message of the report is that of urgently adopting ‘climate-resilient development’ — a developmental model that integrates both adaptation and mitigation to advance sustainable development for all. If this sounds like aiming high, that is because it is; countries no longer have the luxury of focusing on adaptation or mitigation or even development alone.
The report assesses the plethora of technologies and design options, such as solar energy or electric vehicles, that can help countries reduce emissions or become more resilient today at low costs, and in a technically feasible manner. It also points to the fact that there are more synergies than trade-offs between mitigation and adaptation actions and Sustainable Development Goals, although it warns against paying inadequate attention to these trade-offs. Prioritising and addressing equity and social justice in transition processes are shown to be key to climate-resilient development. The report strikes a particularly upbeat note on the co-benefits of climate action for air quality. A cost-benefit analysis suggests that the air quality and health benefits of mitigation outweigh its costs.
While a climate-resilient development pathway is the journey, the destination is net zero emissions at the global level. If sustained, net-zero GHG emissions will result in a gradual decline in global temperatures. However, this may be contingent upon significant carbon dioxide removals, which are challenging to achieve at scale.
How is the world doing in this regard? The report finds some tangible evidence of progress in the proliferation of laws and policies, and confirms the effectiveness of existing policy tools such as regulations and carbon markets. A promising, yet potentially unsung story is that of policy packages, which are a coherent and comprehensive set of policies tied to a particular policy objective that can help countries meet short-term economic goals.
At the same time, several gaps remain in humanity’s response so far. The report points out that there are gaps between modelled sustainable pathways and what countries have pledged (ambition gaps) as well as substantial gaps between what countries pledge and what they actually do (implementation gaps). Delayed action risks locking-in to high carbon infrastructure in this decade, and creating stranded assets and financial instability in the medium term. Therefore, high upfront investments in clean infrastructure are imperative. However, despite sufficient global capital, both adaptation and mitigation financing need to increase many-fold: between three to six times for annual modelled mitigation investments, from 2020 to 2030. The report, thus, paints a picture of progress and innovation in the face of inadequate ambition, implementation, climate finance and investment despite the cost-effectiveness of several response options.
The IPCC AR6 synthesis report is a landmark report because it offers a blueprint for sustainable development, while presenting a sobering account of present and future damages to ecosystems and the most vulnerable amongst us. It is now up to governments and people of the world to act.
6. OPINION-01: Is India in the grip of a ‘stray dog’ crisis?
In recent weeks, there have been many attacks by stray dogs on people, especially children. With an estimated 1.5-6 crore stray canines roaming around the streets in India, questions are being raised about the implementation of municipality laws and cultural attitudes of tolerance towards stray dogs. In a conversation moderated by Jacob Koshy, Shailaja Chandra and Meghna Uniyal map the scale of the public safety issue and provide legal and administrative context. Edited excerpts:
Is there a stray dog crisis in India? And is this a problem unique to India?
Meghna Uniyal: First, some context. This is not an Indian problem; it is very much a global issue. And this is primarily because of our relationship with dogs. We like dogs, we want to keep them and they breed prolifically.
Globally, supply always tends to exceed the demand for dogs. As a result, the surplus animals end up on the streets. The difference (between countries) lies in how we address the problem. The U.S. has a zero-tolerance policy for stray dogs and up to three million dogs and cats are euthanised every year. In India, we allow those animals to end up on the streets, and leave them there. This is in violation of our laws. The Prevention of Cruelty to Animals Act (PCA Act), which is the principal Act for the protection of animals, recognises that dogs are domestic animals, suffer on the streets due to homelessness and also impact human beings, and they should therefore be sheltered, re-homed, removed or euthanised. Our State Municipal Acts, which are meant for the protection of people, also mandate capture and removal, and say they should be sheltered, re-homed or euthanised. Historically, euthanasia was done in a crude, haphazard manner. Municipalities would catch dogs and use the cheapest methods of killing them, such as electrocution, gassing or poisoning. So, the problem became about how these animals could be humanely captured, and our laws implemented in a systematic and logical manner. Now, we have gone from mass killing and employing crude, horrific methods to the other end of the spectrum, which is that we leave all of them on the road. Stray dogs are being identified as community dogs and are now considered part of the community akin to squirrels or birds.
Without human supervision and control, dogs will go back to the feral state, which is what we are seeing on the streets. A dog is a loyal animal and thinks ‘this is my house, I’m being fed here.’ Naturally, these large packs of dogs are becoming territorial and aggressive about public spaces where they are fed.
Municipal authorities had the power to euthanise unclaimed street dogs. The 2001 Animal Birth Control Rules took these powers away by creating a category called ‘street dogs’ as opposed to ‘strays’. The PCA Act, while barring cruelty, doesn’t restrict municipalities from euthanising ‘strays’. How did we end up with laws at cross-purposes?
Shailaja Chandra: Municipal corporations are governed by State Acts, but there is also the Ministry of Urban Development (MUD), which is supposed to bring together the policy and technical aspects. Municipalities are expected to provide assistance in technical matters to States, which in turn give such information to the MUD. The MUD, however, is heavily involved in activities such as construction and sewage management. It does not have the bandwidth or interest to get into sections of laws (governing street animals). The Municipal Acts have rigorous provisions for the containment of the menace caused by street dogs, but these are ignored by officers who generally take their cue from the political milieu in which they operate. The political milieu takes its cue from what the greater number of people seem to believe today, which is that you are doing good to the animal and you are doing ‘punya’ (a charitable act for good karma). The general sense is that stray dogs are a public good. Politicians take a cue from this and municipal authorities take a back seat. Municipal bodies can bring matters under control if they want to, but they will not do it because they have no political push.
But it is also common to see people moving around with sticks and thrashing these animals. So, there seems to be a fair bit of public anger.
MU: This is not only an issue of how nobody follows any laws and the municipalities don’t do what they’re supposed to do. Our laws are there both for the welfare of the people as well as dogs. Laws for the protection of people and animals say that stray animals should be removed from public places, and sheltered, re-homed or euthanised. People do take out a lot of their anger on the animals. When you pit people against dogs and end up giving stray dogs the same rights as your children, retaliatory attacks on these animals increase because there is no way for people to otherwise protect their families physically. So, now we are seeing increasing stray dog attacks inside gated communities and in hospital premises.
The PCA Act is an animal welfare-based legislation, which lays down that animals can be used, owned, managed and even killed but in a humane manner. So, the law is looked at from the lens of human rights. It doesn’t give rights to animals; it vests in us the duty to protect them from unnecessary suffering. But today, we have the Act and a set of subordinate rules that are meant to enforce the Act but make it redundant.
If the power to euthanise strays were restored to, say, municipalities, would it bring down numbers?
SC: Citizens will not accept euthanasia, even in the case of terminally ill animals. This would have to be built into people’s thinking. When your premises are a breeding ground for mosquitoes, municipal corporations levy a fine. If you have somebody polluting the water with chromium plating or electroplating, you get shut down. However, authorities do nothing of the kind when it comes to dogs which bite and cause rabies. This is a public health responsibility, which is a part of a municipal responsibility that ought to be overseen by the Ministries of Health and Family Welfare in the States and at the Centre.
It is out of the question that Indian society will accept euthanasia. What we can do is to follow certain principles which have been agreed upon, but even those have been thrown to the winds. The courts have said there should be designated places for dogs to be fed and that these should be defined by municipal [bodies] and the Animal Welfare Board and the local Resident Welfare Associations. This sounds good. But these three bodies are unlikely to come together for thousands of streets, societies and colonies in a State or in a city. And even if designated places are found, who is going to monitor that this is being observed?
MU: It’s only a small minority of vocal people who make it sound like we don’t kill anything, which is not the case at all. But having said that, euthanasia or sterilisation cannot be the only answer to the problem. For instance, the most fecund and the most prolifically breeding population would have to be sterilised; sick animals, aggressive animals, etc. would have to be euthanised; a segment of the population can be sheltered, and so on. We have to recognise what the Act says, and that is that dogs are domestic companion animals and must be treated as such. They have no role ecologically or otherwise on the streets and in public places without human supervision. This is the starting point of all dog control in the country.
We recently had an update to the Animal Birth Control Rules. Do they work towards solving any of these issues?
MU: Under the new ABC Rules, stray dogs are not even ‘street’ dogs; they are ‘community’ dogs. So, just the name has been changed.
We see that the brunt of the stray dog problem is borne by the poorest, given their disproportionate representation in dog-bite and child-mauling instances. Does something have to be done so that the crisis has more political resonance?
SC: It is the duty of officials to implement the law and of legislators to amend or modify a law if it is not working. Neither has been done. Unless politicians are shown that they are allowing this to go on under their noses, it will not have any effect. Looking at the plethora of cases reported periodically in the press, this story has been going on for 10 or 15 years in the courts. Sometimes the courts give a draconian order; the next day that order is stayed. It is high time that the courts stop the ambivalence, and the law is just interpreted in black and white. And this means the Municipal Corporation Act, and not the Animal Welfare Board Rules.
The most fecund and the most prolifically breeding population would have to be sterilised; sick animals, aggressive animals, etc. would have to be euthanised; a segment of the population can be sheltered, and so on.